Transdermal Testosterone Gel for Female Sexual Interest and Arousal Disorder in Peri- and Post Menopause (TESTA MIND)

The University of Texas System (UT)

Status

Not yet enrolling

Conditions

Testosterone Deficiency

Menopause

Sexual Dysfunction

Libido Disorder

Treatments

Other: Transdermal placebo gel

Other: Transdermal testosterone gel

Study type

Interventional

Funder types

Other

Identifiers

NCT07408440

HSC-MS-26

Details and patient eligibility

About

Hypoactive sexual desire disorder (HSDD) is described as the most common form of female sexual dysfunction, particularly affecting peri- and postmenopausal women and is associated with significant distress and reduced quality of life. The TESTA-MIND study will evaluate the efficacy and safety of a standardized compounded transdermal testosterone gel in a randomized, double-blind, placebo-controlled design to address the lack of FDA-approved options and limited high-quality evidence for treating decreased libido in women.

Full description

Hypoactive sexual desire disorder (HSDD) is the most prevalent form of female sexual dysfunction, particularly affecting peri- and postmenopausal women. Epidemiological studies estimate that between 8-14% of postmenopausal women experience clinically significant reductions in sexual desire that cause distress or interpersonal difficulty, significantly impacting quality of life and intimate relationships. In 2013, with the publication of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), the diagnosis of HSDD was merged with female sexual arousal disorder under the category of Female Sexual Interest/Arousal Disorder (FSIAD). Despite this reclassification, clinical and pharmacological trials continue to use HSDD criteria, given their clearer operationalization and applicability in interventional studies.

Testosterone has long been recognized as a key modulator of female sexual desire and arousal. Observational studies show that circulating androgen levels decrease substantially with age and after menopause. Clinical trials of transdermal testosterone have demonstrated improvements in sexual function, specifically increased frequency of satisfying sexual events, enhanced desire, and reduced distress compared with placebo (7-9). Nevertheless, most clinical studies have utilized pharmaceutical-grade formulations not currently available in the United States, leading many clinicians to rely on compounded testosterone creams.

Currently, no FDA-approved testosterone therapy exists for women, and off-label use varies widely in formulation and administration. Transdermal preparations may provide a physiologic, steady release, and offer practical advantages over patches or systemic therapy, but robust randomized data remain scarce.

Evidence regarding compounded testosterone is limited and highlights concerns about variability in formulation, dosing accuracy, and absorption. Professional societies caution against the routine use of compounded hormones, citing the lack of FDA oversight, inconsistent bioavailability, and absence of long-term safety data. While compounded testosterone may represent a pragmatic solution in the absence of FDA-approved formulations, its use requires rigorous evaluation under standardized trial conditions to establish both efficacy and safety.

The TESTA-MIND study is designed to address this evidence gap by investigating the efficacy and safety of a standardized compounded testosterone gel in peri- and postmenopausal women with decreased libido. By conducting a randomized, double-blind, placebo-controlled trial, the investigators aim to provide high-quality data on the therapeutic role of testosterone in this underserved population, while addressing the clinical uncertainty and professional society concerns that currently limit its widespread adoption.

Enrollment

150 estimated patients

Sex

Female

Ages

40 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Women 40-65 years; peri- or postmenopausal - with one of the following:
- Staging by STRAW+10: stage (-2) or above
- amenorrhea ≥12 mo
- Follicle stimulating hormone in menopausal range
FSIAD diagnosis according to the DSM-5: (3/5 of the following symptoms)
- reduced or no interest in sex
- few or no thoughts about sex
- decreased sexual arousal or pleasure during sexual activity
- reduced or no arousal in response to visual, written, or verbal cues
- infrequent or no initiation of sexual activity within a relationship
- reduced or no sensations in the genitals

They must also have:

symptoms lasting 6 months or more
significant distress about their symptoms
symptoms that are not more accurately explained by a nonsexual mental health disorder, domestic abuse, medication, substance abuse, or another medical condition
- In a stable relationship or sexually active opportunity (as defined by participant)
- If on systemic estrogen ± progestin or local vaginal estrogen: stable dose ≥8 weeks before randomization and agrees to remain stable
- Able to consent and comply with study procedures

Exclusion Criteria

Current or recent (≤8 weeks) androgen therapy, dehydroepiandrosterone (DHEA), or anabolic steroids
Total T above premenopausal upper physiologic range at baseline (>55 ng/dL)
History of hormone-dependent malignancy, untreated endometrial hyperplasia, or active gynecologic malignancy
Active severe psychiatric disorder (e.g., untreated major depression), substance use disorder, or relationship violence that precludes attribution of effect
Uncontrolled thyroid disease, significant liver disease, increased liver enzymes, or high cardiovascular risk judged unsafe by the primary care provider
Pregnancy, attempting conception, or breastfeeding
Dermatologic conditions preventing transdermal use; known hypersensitivity to the gel components